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Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00646542
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : January 9, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Vildagliptin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Study Start Date : March 2005
Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Vildagliptin
Other Name: Galvus
Placebo Comparator: 2 Drug: Placebo



Primary Outcome Measures :
  1. To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ]
  2. To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History T2DM
  • Moderate or Severe Renal Impairment

Exclusion Criteria:

  • Glucose > 270 mg/dL (>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646542


Locations
Argentina
Buenos Aires, Argentina
Australia
Heidelberg Heights, Australia
Canada
Winnipeg, Canada
Costa Rica
Cartago, Costa Rica
Finland
Tampere, Finland
France
Angers, France
Germany
Dormagen, Germany
India
Chennai, India
Norway
Oslo, Norway
Russian Federation
Saint Petersburg, Russian Federation
Spain
Alicante, Spain
Sweden
Lund, Sweden
Sponsors and Collaborators
Novartis

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00646542     History of Changes
Other Study ID Numbers: CLAF237A23137
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013

Keywords provided by Novartis:
Type 2 diabetes, vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs